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临床试验/NCT04564586
NCT04564586Unknown不适用

Developing and Testing a Technology-Based Translation of the Diabetes Prevention Program for Adult Primary Care Patients At-Risk of Developing Type 2 Diabetes Mellitus

Augusta University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
Physical Activity

研究概览

简要总结

DPPFit is a Healthy Lifestyle Intervention designed to reformat the effective strategies of the Diabetes Prevention Program (NDPP) into a tool for use in a primary care setting. DPPFit is a 16-week technology-based intervention for diabetes prevention. In keeping with the National DPP educational sessions, the intervention weeks follow the order and presentation of the N-DPP 16 session topics. The goal is to develop a pragmatic translation of the DPP that is effective in the real-world setting of primary care clinic. The hope is that in doing so, those at risk of developing type II diabetes mellitus will have evidenced-based prevention methods at their disposal.

详细描述

DPPFit is an HLI designed to translate the effective strategies of the National Diabetes Prevention Program (N-DPP) into a tool for use in a primary care setting. The 16-week intervention follows the order of the 16 sessions that make up the core components of the traditional DPP. The novelty in this application is the intervention delivery, in addition to the use of technology to supplement resource and time intensive DPP behavioral strategies. The entire intervention is delivered through automated text messages (SMS/MMS). For any given week, the daily text messages for that week reflect the core session of the DPP (i.e DPPFit Week 1 texts correspond to DPP Session 1). In addition to the automated daily messages, participants are issued a Fitbit and assisted in setting up the Fitbit App on their smart phones. The Fitbit App is considered a standalone mHealth App. The fitness tracker and companion App allow participants to set goals and track food and physical activity. The content of the text messaging is almost entirely from the N-DPP participant notebook (2012). Exceptions to this are a series of prompts to cue participant to use the Fitbit and/or Fitbit App to support the session. These include topics about setting goals in the Fitbit App, how to track food using the App, or how to connect with friends and do challenges on Fitbit.

To be sustainable and feasible in a primary care setting, remote delivery of intervention materials and components is a necessary part of any evidence-based tool to address diabetes prevention. This automated, remote dissemination, technology-based application of the N-DPP components means that intervention delivery and protocol are feasible methods to address diabetes prevention in light of the ongoing Covid-19 health crisis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Non-institutionalized adult patients
  • •Ages 18 - 55 years
  • •Diagnosed as prediabetes or with HbA1c% values between 5.7-6.4%.

排除标准

  • •Prior bariatric surgery
  • •Participation in weight loss program or current weight loss medication.
  • •History of T1DM or T2DM diagnosis
  • •Use of medications to treat glucose intolerance, including biguanides and sulfonylureas.
  • •History of infarction, angina, coronary artery bypass graft surgery, coronary angioplasty, congestive heart failure, or any condition that significantly limits their exercise such as peripheral arterial disease.
  • •BMI (kg/m²)< 18.5

研究组 & 干预措施

Enhanced Intervention Group (EIG)

Other

The Enhanced Intervention Group was a subgroup of the participants that were invited for voluntary weekly meet-n-greet sessions in the Primary Care Clinic. These sessions were information and not educational sessions for the intervention. The entire EIG concept was to test a social component of participants by providing an informal opportunity for a DPPFit social group. The group sessions were terminated after only 5 weeks as a result of the Covid-19 pandemic. They were the only component of the DPPFit study that were face-to-face.

干预措施: DPPFit (Behavioral)

结局指标

主要结局

Physical Activity

时间窗: 6 months

Physical activity days/week, change \> 10% of PA, Kcal/week

Weight Loss

时间窗: 12 Months

Weight Loss by % of change and total weight change (kg)

Inactivity

时间窗: 6 months

Change in Sedentary Time, Mins/day

次要结局

  • Hemoglobin A1c(12 months)
  • Health Related Quality of Life(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Lynn Stewart, PhD, MPH

Principle Investigator

Augusta University

研究点 (1)

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